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Trial record 1 of 8 for:    MT-1186
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Safety Extension Study of Oral Edaravone Administered in Subjects With Amyotrophic Lateral Sclerosis (ALS)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04577404
Recruitment Status : Recruiting
First Posted : October 6, 2020
Last Update Posted : January 13, 2021
Sponsor:
Information provided by (Responsible Party):
Mitsubishi Tanabe Pharma Development America, Inc.

Tracking Information
First Submitted Date  ICMJE September 30, 2020
First Posted Date  ICMJE October 6, 2020
Last Update Posted Date January 13, 2021
Actual Study Start Date  ICMJE October 29, 2020
Estimated Primary Completion Date September 2023   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: September 30, 2020)
Safety and tolerability as measured by incidence of Adverse events (AEs), adverse drug reactions (ADRs), and treatment-emergent adverse events ([TEAEs]) [ Time Frame: Baseline to Week 96 ]
Original Primary Outcome Measures  ICMJE Same as current
Change History
Current Secondary Outcome Measures  ICMJE Not Provided
Original Secondary Outcome Measures  ICMJE Not Provided
Current Other Pre-specified Outcome Measures
 (submitted: October 15, 2020)
  • Change from baseline to week 96 [ Time Frame: Baseline to Week 96 ]
    ALS Functional Rating Scale- Revised (ALSFRS-R). The ALSFRS-R is rating scale (ratings 0 = can't do, to 4 = normal ability) used to determine participants' assessment of their capability and independence in 12 functional activities.
  • Time (days) to death, tracheostomy, or permanent assisted mechanical ventilation (>= 23 hours/day) [ Time Frame: Baseline to Week 96 ]
Original Other Pre-specified Outcome Measures
 (submitted: September 30, 2020)
  • Change from baseline to week 96 [ Time Frame: Baseline to Week 96 ]
    ALS Functional Rating Scale- Revised (ALSFRS-R)
  • Time (days) to death, tracheostomy, or permanent assisted mechanical ventilation (>= 23 hours/day) [ Time Frame: Baseline to Week 96 ]
 
Descriptive Information
Brief Title  ICMJE Safety Extension Study of Oral Edaravone Administered in Subjects With Amyotrophic Lateral Sclerosis (ALS)
Official Title  ICMJE A Phase 3, Multi-center, Open-label, Safety Extension Study of Oral Edaravone Administered Over 96 Weeks in Subjects With Amyotrophic Lateral Sclerosis (ALS)
Brief Summary This is a Phase 3, international, multicenter, open-label, long-term extension study. The primary objective of this study is to evaluate the long-term safety and tolerability of oral edaravone in subjects with Amyotrophic Lateral Sclerosis (ALS) for up to 96 weeks.
Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 3
Study Design  ICMJE Allocation: N/A
Intervention Model: Single Group Assignment
Intervention Model Description:
Single Arm Open Label
Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE Amyotrophic Lateral Sclerosis (ALS)
Intervention  ICMJE Drug: MT-1186
Treatment cycles with daily dosing for 10 days out of a 14-day period, followed by a 14 day drug free period up to 96 weeks of treatment or until the drug is commercially available in that country.
Other Name: Oral Edaravone
Study Arms  ICMJE Experimental: MT-1186
Oral Edaravone administered once daily for 10 days out of 14, followed by a 14-day drug- free period
Intervention: Drug: MT-1186
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Recruiting
Estimated Enrollment  ICMJE
 (submitted: November 10, 2020)
140
Original Estimated Enrollment  ICMJE
 (submitted: September 30, 2020)
100
Estimated Study Completion Date  ICMJE September 2023
Estimated Primary Completion Date September 2023   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria:

  1. Subjects must provide signed and dated informed consent form (ICF) to participate in the study. Subjects must be able (in the judgment of the Investigator) to understand the nature of the study and all risks involved with participation in the study.
  2. Subjects must be willing to cooperate and comply with all protocol restrictions and requirements.
  3. Subjects who successfully completed Study MT-1186-A01

Exclusion Criteria:

  1. Subjects of childbearing potential unwilling to use a highly effective method of contraception from Visit 1 until 3 months after the last dose of study medication.
  2. Subjects who have a significant risk of suicide. Subjects with any suicidal behavior or suicidal ideation of type 4 (active suicidal ideation with some intent to act, without a specific plan) or type 5 (active suicidal ideation with specific plan and intent) based on the C-SSRS at Visit
  3. Subjects who are not eligible to continue in the study, as judged by the Investigator.
  4. Subjects who are unable to take their medications orally or through a PEG/RIG tube.
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE
Contact: Clinical Trials Information Desk, to prevent miscommunication, please email: information@mt-pharma-us.com
Listed Location Countries  ICMJE Japan,   United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT04577404
Other Study ID Numbers  ICMJE MT-1186-A03
2020-000376-38 ( EudraCT Number )
Has Data Monitoring Committee No
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement  ICMJE
Plan to Share IPD: Undecided
Responsible Party Mitsubishi Tanabe Pharma Development America, Inc.
Study Sponsor  ICMJE Mitsubishi Tanabe Pharma Development America, Inc.
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Study Director: Head of Medical Science Mitsubishi Tanabe Pharma Development America, Inc.
PRS Account Mitsubishi Tanabe Pharma Development America, Inc.
Verification Date January 2021

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP